NCT05144854Active, not recruitingPhase 3
A Randomized, Multicenter, Open-label, Phase III Study to Compare the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab, Fluoropyrimidine-based and Platinum-based Chemotherapy (Hereinafter Referred to as "Chemotherapy") Versus Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
Ono Pharmaceutical Co., Ltd.91 sites in 3 countries626 target enrollmentStarted: November 5, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 626
- Locations
- 91
- Primary Endpoint
- Overall survival (OS)
Study Overview
Brief Summary
This study is to compare and evaluate the efficacy and safety of ONO-4538 in combination with ipilimumab and chemotherapy versus chemotherapy in chemotherapy-naïve participants with HER2-negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has been histologically confirmed to be predominant adenocarcinoma
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0 or 1
- •Participants who have a life expectancy of at least 3 months
Exclusion Criteria
- •Participants with a history or complications of multiple cancers
- •Participants with a complication or history of severe hypersensitivity to any other antibody products
- •Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease.
Arms & Interventions
ONO-4538 + ipilimumab + chemotherapy
Experimental
Intervention: ONO-4538 (Drug)
ONO-4538 + ipilimumab + chemotherapy
Experimental
Intervention: Oxaliplatin (Drug)
ONO-4538 + ipilimumab + chemotherapy
Experimental
Intervention: S-1 (Drug)
Chemotherapy
Active Comparator
Intervention: Oxaliplatin (Drug)
Chemotherapy
Active Comparator
Intervention: Capecitabine (Drug)
ONO-4538 + ipilimumab + chemotherapy
Experimental
Intervention: Ipilimumab (Drug)
ONO-4538 + ipilimumab + chemotherapy
Experimental
Intervention: Capecitabine (Drug)
Chemotherapy
Active Comparator
Intervention: S-1 (Drug)
Outcomes
Primary Outcomes
Overall survival (OS)
Time Frame: up to 3 years
(N/A)
Secondary Outcomes
- Objective response rate (ORR) (site investigator assessment)(up to 3 years)
- Best overall response (BOR) (site investigator assessment)(up to 3 years)
- Progression-free survival (PFS) (site investigator assessment)(up to 3 years)
- Duration of response (DOR) (site investigator assessment)(up to 3 years)
- Disease control rate (DCR) (site investigator assessment)(up to 3 years)
- Time to response (TTR) (site investigator assessment)(up to 3 years)
- Maximum percent change in the sum diameters of the target lesions (site investigator assessment)(up to 3 years)
- Progression-free survival after the next line of therapy (PFS2) (site investigator assessment)(up to 3 years)
- Adverse event(Up to 30 days after the last dose)
Investigators
Study Sites (91)
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